Description
Position at Prismatik
Essential Functions:
- Ensures products meetcustomerrequirementsandcomplieswithUSand internationalregulations. Manages new product development and process improvement projects.
- Hires, manages, trains, develops, reviews, and set goals for department and staff.
- Acts as both coach and mentor to team members in areas of problem solving, decision-making, and process improvement.
- Addresses all employee relations matters in a timely manner in coordination with Human Resources.
- Manages and ensures staff’s adherence to Company policies and procedures.
- Manages, modifies, and maintains a complete and comprehensive quality system to support development and contract manufacturing of medical products.
- Oversees the technical side of the Company’s quality system and processes in relation to new product development and process improvement projects.
- Oversees the implementation of new products against market and technical standards.
- Evaluates the product manufacturing process and systems to ensure quality standards and timely and efficient flow of assigned projects.
- Implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Participates in the reviewing of engineering designs to contribute quality requirements and considerations and supports areas in gathering and analyzing data.
- Develops product/organizational quality assurance strategies including new European standards (MDSAP) where applicable.
- Develops and analyzes reportsrelated todepartmentmetrics. Prepares and presents organizational performance and technical information to the management team and associates.
- Refines and implements quality product process plans and systems.
- Developsandreviewsstandard operatingprocedures(SOPs)andother requiredpolicies.
- Serves as quality engineering subject matter expert.
- Serves as the quality representative on new product introduction teams.
- Assures validation and compliance of contract manufacturing and sterilization facilities.
- Manages Quality Engineering activities.
- Organizes procedures and documentation related to areas of responsibility.
- Participates in internal,external, andthird partyaudits.
- Provides technical assistance to other functional areas regarding interpretation of specifications, regulations, material qualifications, first article evaluations, and other quality related subjectstoincreaseunderstanding ofSOPsand guidancedocumentation.
- Performsother relateddutiesand projects asbusinessneeds require at directionof management.
Minimum Qualifications:
- Bachelor’s degree in a related engineering discipline.
- Minimum seven (7) years of related quality assurance experience.
- Previous management and leadership experience.
- Advance knowledge with development and test requirements with recognized standards (ISO 13485).
- Previous experience with New Product Development.
- Demonstrated knowledge of the application of regulatory requirements for low-risk and high-risk software applications using a scalable approach.
- Demonstrated knowledge and understanding on regulations and guidance as related to software development, SaMD.
- Demonstrated ability to implement and improve Software QMS processes.
- Previous quality assurance experience in materials manufacturing, preferred.
Pay range: $114,000 - 152,000/yr
Exact compensation may vary based on skills and experience.
This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.
Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell!
In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!
Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected]. Please indicate the specifics of the assistance needed.
Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.